Bovis Calculus Stativus Treat Acute Cerebral Ischemic Stroke With Impaired Consciousness

This study evaluates whether the combination of Bovis Calculus Stativus (BCS) with conventional treatment can improve impaired consciousness and functional outcomes, and whether it increases serious adverse events in patients with acute cerebral infarction accompanied by impaired consciousness within 72 hours of onset. This is a prospective multicenter randomized controlled double-blind study. In 12 centers in China,220 patients with the following situations will be enrolled: acute ischemic stroke accompanied by impaired consciousness within 72 hours and a GCS score of 3-12. Patients will be randomly assigned into 2 groups according to the ratio of 1:1:

• Experimental Group:

Patients with acute ischemic stroke accompanied by impaired consciousness within 72 hours and a Glasgow Coma Scale (GCS) score of 3-12, who are randomized to the experimental group, will be administered 0.6 g of BCS orally or via nasogastric tube immediately after recruitment. Subsequently, in accordance with guidelines, they will receive standard acute stroke treatment along with 0.6 g of BCS twice daily (bid) orally or via nasogastric tube for 5 consecutive days.

• Placebo Control Group:

Patients with acute ischemic stroke accompanied by impaired consciousness within 72 hours and a GCS score of 3-12, who are randomized to the control group, will be administered a placebo following the same regimen immediately after recruitment. Subsequently, in accordance with guidelines, they will receive standard acute stroke treatment along with the placebo administered orally or via nasogastric tube for 5 consecutive days.

Patients will be assessed using the GCS and NIHSS scores at 24 hours and 8 days after randomization, and the mRS score at 8 days after randomization. A follow-up visit, either in person or via telephone, will be conducted 90 days after randomization to assess the mRS and EQ-5D-5L scores.

Inclusion criteria

• Age ≥ 18 years;
• Clinically diagnosed with ischemic cerebral infarction;
• GCS score: 3-12;
• Time from symptom onset to randomization ≤ 24 hours, including wake-up stroke or stroke without a witness; the time of symptom onset is defined as the "last known well time";
• Pre-stroke mRS score of 0-1;
• Head CT excludes intracranial hemorrhage or other non-ischemic pathologies;
• The participant or legally authorized representative is capable of providing informed consent.

Exclusion criteria

• Use of in BCS within 24 hours before treatment;
• Known pregnancy or breastfeeding, or positive pregnancy test before randomization;
• Allergy to BCS;
• Impaired consciousness caused by other diseases, such as metabolic disorders (e.g., ketoacidosis), trauma, infectious diseases (e.g., pneumonia), neoplastic diseases (e.g., glioma), or toxic conditions (e.g., organophosphate poisoning);
• Requiring or undergoing hemodialysis or peritoneal dialysis; known severe renal insufficiency (glomerular filtration rate <30 mL/min or serum creatinine >220 μmol/L);
• Expected survival time less than 6 months (e.g., due to malignancy, severe cardiopulmonary disease, etc.);
• Participation in other interventional clinical studies that may affect outcome assessment;
• Other conditions deemed by the investigator to make the patient unsuitable for participation or pose significant risks (e.g., inability to understand and/or comply with study procedures and/or follow-up due to mental illness, cognitive or emotional disorders).